Oral Solutions, Syrups, & Oral Solutions, Syrups, & ElixirsElixirs

Physicochemically: Physicochemically:

Solution may be prepared from any Solution may be prepared from any combinationcombination of of solid, liquid, & gas.solid, liquid, & gas.

Pharmaceutically:Pharmaceutically:

Solution are liquid Solution are liquid pharmaceuticalpharmaceutical formulations that formulations that contain one or more chemical substances contain one or more chemical substances dissolveddissolved in a in a suitablesuitable solvent or solvent or mixturemixture of mutually miscible of mutually miscible solvents. solvents.

Solutions are classified based on their use:Solutions are classified based on their use:1.1. Oral solution;Oral solution;

2.2. Otic solution;Otic solution;

3.3. Ophthalmic solution;Ophthalmic solution;

4.4. Topical solution;Topical solution;

5.5. Injection solution.Injection solution.

Solutions are classified based on their formulation:Solutions are classified based on their formulation:1.1. Syrups;Syrups;

2.2. Elixirs;Elixirs;

3.3. Spirits;Spirits;

4.4. Aromatic water;Aromatic water;

5.5. Tincture or fluid extract;Tincture or fluid extract;

6.6. Injection solution.Injection solution.

Oral solution contains:Oral solution contains:

1.1. ………………………………;;

2.2. ………………………………;;

3.3. ………………………………;;

4.4. ……………………………… ……………………………… (i.e. preservatives, (i.e. preservatives, antioxidants,..etc).antioxidants,..etc).

In In compoundingcompounding pharmaceutical solution, pharmaceutical solution, pharmacist pharmacist must bemust be aware aware of:of:

1.1. ……………… ……………… of the solute;of the solute;

2.2. ……………… ……………… of common pharmaceutical of common pharmaceutical solventssolvents;;

3.3. ………………………………with regard to all components of with regard to all components of formulation;formulation;

Dissolution & SolubilityDissolution & Solubility

I.I. The Process of Dissolution & Kinetic theory The Process of Dissolution & Kinetic theory of Matter:of Matter:

In In solid statesolid state of matter (condensed phase) the of matter (condensed phase) the thermal thermal motionsmotions of molecules or atoms are of molecules or atoms are reducedreduced to the to the minimumminimum, so that the , so that the ………………………………forces result forces result in a in a coherentcoherent masses of molecules (TD masses of molecules (TD organization).organization).

In gaseous phases the molecules move In gaseous phases the molecules move ……………………………… within the container, because they within the container, because they have very have very weakweak intermolecular bonds. intermolecular bonds.

In In liquidliquid condensed systems the thermal motion of condensed systems the thermal motion of molecules aremolecules are > > than that of the than that of the solidssolids but are but are << than that of the than that of the gasgas. This is . This is duedue to the to the naturenature of the of the ………………………………between the molecules of the between the molecules of the liquid, which are stronger than that of the gas but liquid, which are stronger than that of the gas but weaker than that of the solid. weaker than that of the solid.

Therefore:Therefore:

1.1. Liquid has Liquid has ………………………………structure; structure; 2.2. The liquid tends to contain a The liquid tends to contain a smallsmall amount of free amount of free

spacesspaces or volumes called or volumes called holesholes;;3.3. When the solute dissolves in the liquid the When the solute dissolves in the liquid the ↑↑ in in

volumevolume is is << than the than the expectedexpected..

G = G = H – T.H – T.SS eq. 1eq. 1

G, is the variation in the free energyG, is the variation in the free energyH, is the variation in the enthalpy H, is the variation in the enthalpy S, is the variation in the entropyS, is the variation in the entropyT, is the thermodynamic temperature of the system.T, is the thermodynamic temperature of the system. Therefore:Therefore: If If H is H is (-)(-), the transformation is called , the transformation is called exothermic exothermic

(spontaneous dissolution).(spontaneous dissolution). If If H is H is (+)(+), the transformation is called , the transformation is called endothermicendothermic (non- (non-

spontaneous dissolution).spontaneous dissolution). If If H is H is 00, the transformation is, the transformation is in in equilibriumequilibrium (ideal (ideal

solution).solution).

S is usually S is usually (+)(+) for any process like dissolution. for any process like dissolution.

In real solutions a change in the In real solutions a change in the enthalpyenthalpy will therefore will therefore accompany the dissolution.accompany the dissolution.

From equation 1 we fined that the From equation 1 we fined that the dissolutiondissolution will will occur if occur if HH is either is either negativenegative or if it is or if it is positivepositive but but << than T. than T. S.S.

H = H = HHcrcr + + HHsolvsolv eq. 2eq. 2

HHcrcr is the is the absorbedabsorbed heat heat when the crystalline when the crystalline

moleculemolecule were were separatedseparated by an by an infiniteinfinite distance distance againstagainst the effect of their the effect of their intermolecularintermolecular attractiveattractive forcesforces..

HHsolvsolv is the enthalpy of solvation & it is the is the enthalpy of solvation & it is the absorbed absorbed

heatheat when the when the solutesolute molecules are molecules are immersedimmersed in the in the solvent.solvent.

HHcrcr is always is always (+)(+)..

HHsolvsolv is always is always (-)(-)..

But in must cases But in must cases HHcrcr >> HHsolvsolv So So H is usually H is usually (+)(+) & the process is & the process is endothermicendothermic. .

II.II. SolubilitySolubilityG is the required energy to perform a work.G is the required energy to perform a work.

G = 0 at equilibrium.G = 0 at equilibrium.

Solution achieved when Solution achieved when equilibriumequilibrium is is establishedestablished between between dissolveddissolved & & un-dissolvedun-dissolved solute in a solute in a dissolutiondissolution process is termed a process is termed a saturated saturated solution.solution.

Solubility is the Solubility is the maximummaximum amount of amount of solutesolute that can that can be dissolved in be dissolved in certaincertain solvent at solvent at constantconstant temperature & pressure. temperature & pressure.

Types of interactions between molecules & Solubility:Types of interactions between molecules & Solubility:

1.1. Dipole-dipoleDipole-dipole interactions (Van der Walals forces); interactions (Van der Walals forces);

2.2. Ion-dipoleIon-dipole & & H-bondsH-bonds..

H-bondsH-bonds are very important because of are very important because of smallsmall size & size & largelarge electrostatic field.electrostatic field.

Hydrogen bonds involve strongly Hydrogen bonds involve strongly electronigativeelectronigative atoms (i.e. O atoms (i.e. O22, ,

ClCl22, F, F22,..etc.),..etc.)

When solute dissolves:When solute dissolves:

1.1. The The ……………………………… ( (attractiveattractive forces) between: forces) between:

a)a) the the ownown molecules of molecules of solutesolute & &

b)b) the the ownown molecules of molecules of solventsolvent areare ……………………………… ……………………………… ( (attractiveattractive forces) between: forces) between:

molecules of molecules of solutesolute & & solventssolvents..

Methods for Methods for increasingincreasing drug solubility: drug solubility:

1.1. SelectionSelection of ………………; of ………………;

2.2. SelectionSelection of ………………of the medicinal agent; of ………………of the medicinal agent;

3.3. ………………………………;;

4.4. ………………………………………………………………, of the , of the solventsolvent; ;

5.5. ………………………………::

II22 + KI + KI K K++II--33

solubility of Isolubility of I22 is 1g/3000mL, while solubility of KI is 1g/3000mL, while solubility of KI--3 3 is is

2g/100mL2g/100mL

6.6. ………………………………: : MostMost medicinal agents medicinal agents need heatneed heat for dissolution (………………); for dissolution (………………);

FewFew drugs exhibit a drugs exhibit a decreasedecrease in solubility with a in solubility with a riserise in in temperature (………………).temperature (………………).

7.7. Variation of Variation of chemicalchemical & & physicalphysical properties of both properties of both ……………………………… & ………………such as:& ………………such as:Pressure, acidity or basicity of the solution.Pressure, acidity or basicity of the solution.

The The solubilitysolubility of a of a purepure chemicalchemical at given at given PP & & TT is is constantconstant but its but its dissolutiondissolution rate depends on factors such as: rate depends on factors such as:

Particle size & AParticle size & Aspsp of the solute & agitation during dissolution of the solute & agitation during dissolution process. process.

Steps of solubility determination:Steps of solubility determination:

1.1. ………………………………………………………………of the drug at given T & P;of the drug at given T & P;

2.2. AnalyzeAnalyze ………………………………………………………………the the amountamount of of drugdrug present present in a given amount of solution;in a given amount of solution;

3.3. CalculationCalculation of of ………………………………………………………………..

Method of expressing solubility when exact solubility is unknown Method of expressing solubility when exact solubility is unknown (USP method):(USP method):

Table 1 & 2Table 1 & 2

There is There is no exact ruleno exact rule for for predictingpredicting exactexact solubilitysolubility of a drug in a of a drug in a specific solvent.specific solvent.

The The mostmost frequently frequently used ruleused rule is: is: Like Dissolve LikeLike Dissolve Like so, so,

Organic compounds (bases & acids) are more soluble in alcohol than in Organic compounds (bases & acids) are more soluble in alcohol than in water.water.

PharmaceuticalPharmaceutical scientist can scientist can estimateestimate general solubility of a drug general solubility of a drug basedbased on its on its chemicalchemical structure such as: structure such as:

1.1. ………………………………in organic compounds (i.e. polar groups increase water in organic compounds (i.e. polar groups increase water solubility);solubility);

2.2. ………………………………;;

3.3. ………………………………; ; OH

OH OH

OH

General rules of solubility for Inorganic Molecules:General rules of solubility for Inorganic Molecules:

General rules of solubility for Organic Molecules:General rules of solubility for Organic Molecules:1.1. MoleculesMolecules with with …………………………………… functional group are functional group are

water-solublewater-soluble to a total length of to a total length of ……………………………………;;2.2. BranchedBranched chain molecules are chain molecules are …………………………………… than than

…………………………………… isomers; isomers;3.3. …………………………………… decrease solubility;decrease solubility;

4.4. …………………………………… between between solventsolvent & & drugdrug results in results in ↑↑ of of solubility.solubility.

How pharmacists select pharmaceutical solvent?How pharmacists select pharmaceutical solvent?1.1. ……………………………………;;2.2. ……………………………………;;3.3. ……………………………………;;4.4. …………………………………… with with drugdrug & & …………………………………… in the in the

formulation;formulation;5.5. ……………………………………(i.e. palatability, clarity and smell).(i.e. palatability, clarity and smell).

Water is the most used solvent in pharmaceutics;Water is the most used solvent in pharmaceutics;

Some solvents for oral preparations:Some solvents for oral preparations:I.I. Alcohol, USPAlcohol, USP (Ethyl Alcohol, Ethanol, (Ethyl Alcohol, Ethanol, CHCH33CHCH22OHOH))

Alcohol, USP, is Alcohol, USP, is …………………………………… CH CH33CHCH22OH when OH when determined at 15.56 °C determined at 15.56 °C

The above The above T T is the is the …………………………………… for alcohol for alcohol determination.determination.

II.II. Dehydrated Alcohol, USPDehydrated Alcohol, USP, contains , contains …………………………………… CH CH33CHCH22OH.OH.

The above alcohol is used for The above alcohol is used for …………………………………… when when anhydrous conditions are desired.anhydrous conditions are desired.

Alcohol is considered as pharmaceutical Alcohol is considered as pharmaceutical ……………………………………

Alcohol has Alcohol has …………………………………… activity which make it an activity which make it an acceptable preservative.acceptable preservative.

Alcohol is used Alcohol is used in combinationin combination with with ……………………………………, , ……………………………………, & , & …………………………………… to to ↓↓ the amount the amount of alcohol due to its of alcohol due to its ……………………………………..

The The …………………………………… of alcohol of alcohol …………………………………… its use its use in in OTCOTC..

The The FDAFDA regulation for regulation for OTCOTC product intended for product intended for pediatricpediatric use: use:

1.1. < 6< 6 years [ethanol content years [ethanol content ……………………………………]]2.2. 6 – 126 – 12 years [ethanol content years [ethanol content ……………………………………]]3.3. > 12> 12 years [ethanol content years [ethanol content ……………………………………]]

III.III. Diluted Alcohol, NFDiluted Alcohol, NF1.1. Diluted alcohol, NF, is prepared by Diluted alcohol, NF, is prepared by mixingmixing equalequal volumes of volumes of

AlcoholAlcohol, , USPUSP, & , & PurifiedPurified water, water,2.2. The The sumsum of the two of the two volumesvolumes is is 3% less3% less than the than the expectedexpected..3.3. [Alcohol] of [Alcohol] of 50 ml50 ml of alcohol 96 % + of alcohol 96 % + 50 ml50 ml of water is of water is 49%.49%.

96 alcohol96 alcohol :: 100 ml solution100 ml solution

XX11 :: 50 ml50 ml

XX11 == 50 . 96 50 . 96 == 47.3 ml47.3 ml of alcohol in of alcohol in 50 ml50 ml of solution. of solution.

100100

Thus, mixing 50 ml of alcohol, USP + 50 ml water we will have 97 ml of Thus, mixing 50 ml of alcohol, USP + 50 ml water we will have 97 ml of final volume with the following exact concentration:final volume with the following exact concentration:47.3 ml alcohol47.3 ml alcohol :: 97 ml solution97 ml solution

XX22 :: 100 ml of solution100 ml of solution

XX22 == 47,3 . 100 47,3 . 100 == 49.2 % v/v49.2 % v/v..

9797

Glycerin, USP (Glycerol), Glycerin, USP (Glycerol), CHCH22OHCH(OH)CHOHCH(OH)CH22OHOH

1.1. Glycerin is a Glycerin is a …………………………………… with a with a ……………………………………

2.2. …………………………………… & & …………………………………… miscible. miscible.

3.3. It has It has …………………………………… capacity comparable with capacity comparable with alcoholalcohol..

4.4. Its high viscosity (Its high viscosity (ηη) slow its ) slow its …………………………………… capacity, so, capacity, so, heatheat will will ↓ ↓ ηη & & ↑↑ dissolvingdissolving capacity of capacity of glycerol.glycerol.

5.5. It has It has …………………………………… capacity. capacity.

6.6. It is It is usedused in many in many …………………………………… formulations. formulations.

Propylene Glycol, USP, Propylene Glycol, USP, CHCH33CH(OH)CHCH(OH)CH22OHOH

1.1. …………………………………… & & …………………………………… liquid. liquid.

2.2. …………………………………… & & …………………………………… miscible . miscible .

3.3. Has Has …………………………………… properties. properties.

4.4. Its Its …………………………………… properties are properties are similarsimilar to glycerin. to glycerin.

5.5. It It …………………………………… glycerin in many modern formulations. glycerin in many modern formulations.

Water:Water:

I.I. Drinkable or Tap water;Drinkable or Tap water;

II.II. Purified water, USP, HPurified water, USP, H22OO

CharacteristicsCharacteristics of drinkable or tap water: of drinkable or tap water:

1.1. ……………………………………, , …………………………………… and and …………………………………… liquid;liquid;

2.2. Total Total …………………………………… is is ≤ 0.1≤ 0.1 %w/v; %w/v;

3.3. ……………………………………;;

4.4. …………………………………………..

Drinkable water Drinkable water can notcan not be be usedused in in …………………….……………………. because: because: Chemical Chemical …………………….……………………. (i.e. precipitation, (i.e. precipitation, discoloration, & effervescence).discoloration, & effervescence).

It is It is usedused only for only for …………………….……………………. & & cleaningcleaning of of pharmaceutical machinery.pharmaceutical machinery.

Purified water, USP, HPurified water, USP, H22O:O:1.1. Total Total solidsolid content is content is ≤ 0.001≤ 0.001 %w/v (1mg/100ml). %w/v (1mg/100ml).2.2. It is used for It is used for cosmeticcosmetic, & , & pharmaceuticalpharmaceutical preparation preparation Types of Purified water:Types of Purified water:

I.I. …………………….……………………. water (ion-exchange method); water (ion-exchange method);

II.II. …………………….……………………. water; water;

III.III. …………………………………………..(RO) water.(RO) water.

Purified water is prepared from water complying with the Purified water is prepared from water complying with the federal environmental protection agency with respect to federal environmental protection agency with respect to drinking water.drinking water.

I.I. Demineralized or De-ionized waterDemineralized or De-ionized waterThis water is obtained This water is obtained …………………….……………………. method. method.Ion-exchange equipment involves the use of water Ion-exchange equipment involves the use of water

insoluble resins:insoluble resins:1.1. ………………………………………….. or acid exchanger resin: or acid exchanger resin:

H-Resin + MH-Resin + M++ + X + X-- + H + H22O M-Resin + H O M-Resin + H ++ + + XX-- + H + H22OO

2.2. ………………………………………….. or base exchanger resin: or base exchanger resin:

Resin-NHResin-NH22 + H + H++ + X + X-- + H + H22O Resin-NHO Resin-NH22.HX .HX + H+ H22O O

II.II. Reverse OsmosisReverse Osmosis (RO): (RO): Industrially known as Industrially known as cross-flowcross-flow or; or; Known as Known as Tangential flowTangential flow membrane filtration: membrane filtration:

1.1. A A pressurized streampressurized stream of water is passed parallel to of water is passed parallel to the the inner inner side of a filter membrane core;side of a filter membrane core;

2.2. A A …………………….……………………. of the of the …………………….……………………. water water, or , or influent, influent, permeatespermeates the membrane as the membrane as filtratefiltrate;;

3.3. While the balance of the water While the balance of the water sweeps tangentiallysweeps tangentially along the membrane;along the membrane;

4.4. This This last onelast one exit the system exit the system withoutwithout being being filteredfiltered;;

5.5. The The filteredfiltered portion is called portion is called …………………….…………………….

(purified);(purified);

6.6. The The non-filterednon-filtered portion is called portion is called …………………….…………………….

(rejected);(rejected);

1.1. In Reveres Osmosis the flow is from the high concentrated solution to In Reveres Osmosis the flow is from the high concentrated solution to the less concentrated. the less concentrated.

RemovingRemoving of particles depends on of particles depends on pore sizepore size of cross-flow of cross-flow filter membrane:filter membrane:

1.1. ………………………………………….. removes bacteria ( removes bacteria (0.1 – 2 µm0.1 – 2 µm););2.2. ………………………………………….. removes viruses ( removes viruses (0.01 – 0.1 µm0.01 – 0.1 µm););3.3. ………………………………………….. removes organic compounds MW 300 – 1000 ( removes organic compounds MW 300 – 1000 (0.001 – 0.001 –

0.01 µm0.01 µm););

4.4. RORO removes virtually all viruses, bacteria, pyrogens, organic molecules & removes virtually all viruses, bacteria, pyrogens, organic molecules & 90-99% of all ions (90-99% of all ions (≤ 0.001 µm≤ 0.001 µm).).

III.III. Distilled waterDistilled water

The first portion of the distilled water (10 – 20%) must be The first portion of the distilled water (10 – 20%) must be discharged.discharged.

The last 10% of the original water for distillation must be The last 10% of the original water for distillation must be discharged.discharged.

Preparation of SolutionPreparation of Solution

Most Pharmaceutical solutions are Most Pharmaceutical solutions are unsaturatedunsaturated..

Thus, the amount of Thus, the amount of …………………….……………………. than the than the …………………….……………………. of the volume of of the volume of solventsolvent employed.employed.

Methods of expressing strength of pharmaceutical Methods of expressing strength of pharmaceutical solutions:solutions:

Table 6-4Table 6-4

Pharmacists may employ the Pharmacists may employ the followingfollowing methods to methods to increaseincrease the the dissolutiondissolution rate of a drug: rate of a drug:

1.1. …………………………………………..;;

2.2. …………………………………………..;;

3.3. Use of Use of …………………….…………………….;;

4.4. Rigorous Rigorous …………………….……………………...

Increase of rate of dissolution is important since most Increase of rate of dissolution is important since most pharmaceutical solutions are unsaturated.pharmaceutical solutions are unsaturated.

Heat use must Heat use must not exceednot exceed the the …………………….……………………. due to: due to:

1.1. Drug Drug …………………….…………………….;;

2.2. Presence of Presence of …………………….……………………., or solvents, or additives;, or solvents, or additives;

3.3. ………………………………………….. dissolution of certain drugs (i.e. Ca(OH) dissolution of certain drugs (i.e. Ca(OH)22))

Water solubility of calcium hydroxide topical solution, Water solubility of calcium hydroxide topical solution, USP:USP:

1.1. 140 mg/100 ml at 25 °C;140 mg/100 ml at 25 °C;

2.2. 170 mg/100 ml at 15 °C.170 mg/100 ml at 15 °C.

The The storagestorage temperature temperature …………………….……………………. the [] of the [] of the resultant solution.the resultant solution.

MostMost oral solutions are prepared by oral solutions are prepared by …………………….……………………. …………………….……………………. of solutes in the solvent or of solutes in the solvent or solvent mixtures.solvent mixtures.

IndustriallyIndustrially very large very large …………………….……………………. are used. are used.

If heatIf heat is is requiredrequired, a , a …………………….……………………. controlled controlled mixersmixers tanks may be utilized. tanks may be utilized.

Oral Solutions & Preparations for Oral SolutionOral Solutions & Preparations for Oral SolutionOral solution Oral solution usually containsusually contains::

1.1. Flavorants & Colorants;Flavorants & Colorants;

2.2. Sweetening agents;Sweetening agents;

3.3. Stabilizers for chemical & physical stability (i.e. Stabilizers for chemical & physical stability (i.e. antioxidants);antioxidants);

4.4. Preservatives to prevent microbial growth (i.e. mp Preservatives to prevent microbial growth (i.e. mp & pp);& pp);

CompoundingCompounding pharmacists must be pharmacists must be awareaware of: of:Chemical & physical incompatibilities between the Chemical & physical incompatibilities between the

various componentsvarious components of solution. of solution.

These These …………………….……………………. results in drug results in drug …………………….……………………. & loss of potency. & loss of potency.

EstersEsters of parahydroxybenzoic acid (i.e. mp, ep, pp … of parahydroxybenzoic acid (i.e. mp, ep, pp …etc.) have the etc.) have the …………………….……………………. to to …………………….……………………. into certain into certain …………………….……………………. oils.oils.

This This partitionpartition ↓ their ↓ their preservationpreservation efficacy. efficacy.

Tools for oral solution administrations:Tools for oral solution administrations:

1.1. Tea spoonful = 5 mL;Tea spoonful = 5 mL;

2.2. Table spoonful = 15 mL;Table spoonful = 15 mL;

3.3. …………………………………………..;;

4.4. …………………………………………....

Few solutions have large doses (i.e. Mg citrate oral Few solutions have large doses (i.e. Mg citrate oral solution, USP, with actual dose of 200 mL).solution, USP, with actual dose of 200 mL).

Dry Mixtures for SolutionDry Mixtures for SolutionFor drugs (i.e. antibiotics) that have For drugs (i.e. antibiotics) that have insufficientinsufficient stability stability

in water to meet in water to meet …………………….……………………. shelf-life shelf-life periodsperiods..

Manufacturers provide these Manufacturers provide these …………………….……………………. in in drydry powder or granules powder or granules readyready for for …………………….……………………...

The dry mixture The dry mixture containscontains all all …………………….……………………. including including …………………….……………………., , …………………….……………………., sweeteners, … etc., sweeteners, … etc.

Once they are reconstituted with addition of solvent/s, Once they are reconstituted with addition of solvent/s, the the …………………….……………………. is is …………………….……………………. from from 77 to to 14 14 daysdays depending on drug & storage conditions. depending on drug & storage conditions.

PatientPatient must be must be …………………….……………………. to to …………………….……………………. the the remainingremaining part of part of formulationformulation after the patient after the patient completescompletes his course therapy. his course therapy.

Oral SolutionsOral SolutionsPharmacist must advise patient on:Pharmacist must advise patient on:1.1. …………………………………………..;;2.2. …………………………………………..;;3.3. …………………………………………..;;4.4. …………………………………………....

Pharmacists must know:Pharmacists must know:Characteristics of Characteristics of solventsolvent used in the formulation to: used in the formulation to:AdviseAdvise patient about patient about mixingmixing formulation with formulation with JuiceJuice, , milkmilk

or other or other beveragesbeverages..

Product Product labellabel & & PackagePackage insert must contain insert must contain …………………….……………………. about about …………………….……………………. used in used in formulation.formulation.

Table 6-8Table 6-8

Oral Rehydration SolutionsOral Rehydration SolutionsDiarrheaDiarrhea is a normal is a normal …………………….……………………. body body …………………….…………………….

against against noxiousnoxious or or toxictoxic substance e.g., Rotavirus, E. coli. substance e.g., Rotavirus, E. coli.

Diarrhea is characterized by an Diarrhea is characterized by an ↑ ↑ frequency of frequency of looseloose watery watery stools. stools.

DuringDuring diarrhea the diarrhea the …………………….……………………. in smooth intestine in smooth intestine largely largely exceedexceed the the capacitycapacity of large intestine to of large intestine to reabsorb itreabsorb it..

Diarrhea can Diarrhea can leadlead to to dehydrationdehydration & ultimately & ultimately deathdeath, , particularly in particularly in pediatricpediatric & & elderlyelderly Patients. Patients.

Over Over 5 5 million children million children < 4< 4 years age years age diedie due to diarrhea each due to diarrhea each year worldwide.year worldwide.

LossLoss of fluid during diarrhea of fluid during diarrhea resultsresults in loss of Na in loss of Na++, K, K++ & & HCO3 HCO3 --..

Sever loss in the above ions results in:Sever loss in the above ions results in:1.1. ………………………………………….. shock; shock;2.2. …………………………………………..;;3.3. …………………………………………..;;4.4. ………………………………………….., which if continuous lead to malnutrition., which if continuous lead to malnutrition.

Treatment approach of diarrhea:Treatment approach of diarrhea:1.1. Allow diarrhea to Allow diarrhea to …………………….……………………. & & …………………….……………………. it it

quickly.quickly.2.2. ReplaceReplace the lost the lost fluidfluid & & electrolyteselectrolytes with an oral with an oral rehydrationrehydration

solution to avoid dehydration.solution to avoid dehydration.3.3. These are These are OTC OTC products products effectiveeffective in patients with mild in patients with mild

volume volume depilationdepilation of 5 – 10% of body weight. of 5 – 10% of body weight.

Composition of oral rehydration solutionComposition of oral rehydration solution

The active absorption of glucose in the smooth intestine The active absorption of glucose in the smooth intestine promotespromotes:: Absorption of NaAbsorption of Na++, which , which promotespromotes anion (X anion (X--) absorption,) absorption, NaX absorption NaX absorption promotespromotes H H22O absorption.O absorption.

Therefore, the composition of oral solution is:Therefore, the composition of oral solution is:

1.1. Glucose: 110 mM ≈ 2% w/v.Glucose: 110 mM ≈ 2% w/v.

2.2. NaNa++: 60 mEq/L.: 60 mEq/L.

3.3. HCOHCO33- - & /or citrate to correct blood acidosis. & /or citrate to correct blood acidosis.

A typical oral rehydration solution contains:A typical oral rehydration solution contains:1.1. 45 mEq Na45 mEq Na++,,

2.2. 20 mEq K20 mEq K++,,

3.3. 35 mEq Cl35 mEq Cl--, ,

4.4. 30 mEq citrate, 30 mEq citrate,

5.5. 25 g of dextrose per liter.25 g of dextrose per liter. These formulations are available il liquid or powder/ packet form These formulations are available il liquid or powder/ packet form

for reconstitution.for reconstitution.

Oral Colonic Lavage SolutionOral Colonic Lavage Solution Oral Oral …………………….……………………. solution is used to prepare the bowel for solution is used to prepare the bowel for

…………………….……………………. examinations (i.e. examinations (i.e. colonoscopycolonoscopy).).

The The …………………….……………………. is a long narrow flexible tube containing a is a long narrow flexible tube containing a tiny tiny lightlight & & camera camera at one end. The camera carries pictures of your rectum at one end. The camera carries pictures of your rectum & colon to a television screen, where they can be viewed by the & colon to a television screen, where they can be viewed by the doctor & nurse. doctor & nurse.

A Typical formulation of oral colonic lavage solution A Typical formulation of oral colonic lavage solution is:is:

1.1. Polyethylene Glycol 3350Polyethylene Glycol 3350 236.00 g236.00 g2.2. Sodium sulfateSodium sulfate 22.74 g22.74 g3.3. Sodium bicarbonateSodium bicarbonate 6.74 g6.74 g4.4. Sodium ChlorideSodium Chloride 5.86 g5.86 g5.5. Potassium ChloridePotassium Chloride 2.972.97

In 4800 mL disposable containerIn 4800 mL disposable containerThe recommended adult dose of this formulation is:The recommended adult dose of this formulation is:1.1. 4 liters of the solution before the GI procedure.4 liters of the solution before the GI procedure.2.2. The solution must be drunk as 240 mL every 10 minutes The solution must be drunk as 240 mL every 10 minutes

until complete consume of the solution.until complete consume of the solution.

SyrupsSyrups

Syrups are Syrups are concentratedconcentrated, aqueous preparations of a , aqueous preparations of a sugarsugar or or sugar-substitutesugar-substitute with or without added with or without added

flavoring agents & medicinal substances.flavoring agents & medicinal substances.

There are There are 33 types: types:

1.1. ………………………………………….., which is a bout saturated sugar , which is a bout saturated sugar solution without flavour or medicine.solution without flavour or medicine.

2.2. ………………………………………….. : is a flavored simple syrup. : is a flavored simple syrup.

3.3. ………………………………………….. : is a syrup containing medicinal : is a syrup containing medicinal agent.agent.

Syrups are Syrups are useful alternativeuseful alternative of of solidsolid dosage forms for dosage forms for children & elderly.children & elderly.

Pharmacists can Pharmacists can prepareprepare syrups in their syrups in their own own pharmacy.pharmacy.

Requirements for preparing syrups:Requirements for preparing syrups:

1.1. ………………………………………….. of drug of drug solubilitysolubility & & stabilitystability;;

2.2. ………………………………………….. must be considered case by case. must be considered case by case.

Medicated syrups are commercially prepared by:Medicated syrups are commercially prepared by:

1.1. ………………………………………….. sucrose & purified water ( simple sucrose & purified water ( simple syrup is obtained);syrup is obtained);

2.2. ………………………………………….. & & …………………….……………………. the therapeutic the therapeutic agent;agent;

3.3. ………………………………………….. of flavoring & coloring agents; of flavoring & coloring agents;

4.4. AdditionAddition other necessary & desirable ingredient. other necessary & desirable ingredient.

Components of commercial syrups:Components of commercial syrups:

1.1. Sugar (sucrose) or sugar-substitutes used to Sugar (sucrose) or sugar-substitutes used to provide sweetness & viscosity;provide sweetness & viscosity;

2.2. …………………………………………..;;

3.3. ………………………………………….. agents; agents;

4.4. …………………………………………..;;

5.5. ………………………………………….. solvents; solvents;

6.6. ………………………………………….. agents; agents;

7.7. Thickeners, or stabilizers. Thickeners, or stabilizers.

Advantages of medicated syrups:Advantages of medicated syrups:1.1. ………………………………………….. of administration of a liquid form of a of administration of a liquid form of a badbad tasting tasting

drug;drug;2.2. This This …………………….……………………. attractiveattractive for youngsters. for youngsters.3.3. ………………………………………….., since these dosage forms , since these dosage forms …………………….…………………….;;4.4. The The …………………….……………………. & & …………………….……………………. syrups have a syrups have a soothingsoothing

effect on the effect on the irritatedirritated tissue of the throat as they pass over them. tissue of the throat as they pass over them.

In summary:In summary:1.1. AnyAny …………………….……………………. may be added to flavored syrup. may be added to flavored syrup.2.2. However, However, carecare must be played to must be played to …………………….……………………. between between

all components of the syrup.all components of the syrup.

Since Since therethere are are acidicacidic, , basicbasic & & neutralneutral flavored syrups, flavored syrups, attentionattention must be exercised to the must be exercised to the …………………….……………………. of the of the added added drugdrug. .

Table 6-6Table 6-6Table 6-7Table 6-7

Sucrose & Non-Sucrose Based SyrupsSucrose & Non-Sucrose Based Syrups Characteristics of simple sucrose syrup (85% w/v):Characteristics of simple sucrose syrup (85% w/v):1.1. …………………………………………..; ; 2.2. …………………………………………..;;3.3. Preservation (hypertonic solution);Preservation (hypertonic solution);4.4. High density & specific gravity (s.g. =1.313)High density & specific gravity (s.g. =1.313)

Specific gravity Specific gravity == weight of substance weight of substance weigh of equal volume water weigh of equal volume water

1.313 1.313 == w w , thus, weight of 100 mL syrup is 131.3, thus, weight of 100 mL syrup is 131.3

100100131.3g - 85g = 46.3 g or mL of water in the syrup.131.3g - 85g = 46.3 g or mL of water in the syrup.Thus, 46.3 g of water are mixed with 85 g of sucrose to Thus, 46.3 g of water are mixed with 85 g of sucrose to

give syrup 65.5% w/w or 85%w/v.give syrup 65.5% w/w or 85%w/v.

SolubilitySolubility of sucrose in water is of sucrose in water is 1g /0.5 ml1g /0.5 ml of water, thus, of water, thus, 85 g85 g of of sucrose need sucrose need 42.5 g42.5 g of water. of water.

Thus, the Thus, the excessexcess of water in of water in 85%85% w/v syrup is w/v syrup is 3.8 3.8 mL.mL.

These These 3.8 mL3.8 mL of water are of water are freefree of sucrose. of sucrose.

This This meansmeans that that syrupsyrup is is Not saturatedNot saturated but but …………………….……………………...IfIf the syrup was completely the syrup was completely …………………….……………………., , any variationany variation of of storagestorage

conditions (i.e. cooling) might produce sucrose conditions (i.e. cooling) might produce sucrose …………………….……………………. from from the syrup.the syrup.

This would This would startstart a chain of a chain of …………………….……………………. & sucrose & sucrose …………………….……………………...

The The syrupsyrup would would thenthen be very much be very much unsaturatedunsaturated & & suitablesuitable for for microbialmicrobial growth. growth.

Since many Since many officialofficial syrups are syrups are not saturatednot saturated suitable suitable …………………….……………………. in in the formulation. the formulation.

In special circumstances sucrose may be replaced in In special circumstances sucrose may be replaced in whole or in part by:whole or in part by:

I.I. …………………….……………………. substances (materials converted to substances (materials converted to glucose in the body) such as:glucose in the body) such as:

1.1. Other sugars (i.e. dextrose);Other sugars (i.e. dextrose);2.2. Non-sugars (i.e. sorbitol, glycerin propylene glycol ..etc.).Non-sugars (i.e. sorbitol, glycerin propylene glycol ..etc.).

II.II. …………………….……………………. substances such as methylcellulose substances such as methylcellulose (MC) or hydroxyethylcellulose HEC).(MC) or hydroxyethylcellulose HEC).

Characteristics of MC & HEC:Characteristics of MC & HEC:1.1. ………………………………………….. & absorbed in the blood stream; & absorbed in the blood stream;2.2. ………………………………………….. viscosity or vehicle; viscosity or vehicle; 3.3. ………………………………………….. & favors results in facsimile of a true & favors results in facsimile of a true

syrups.syrups.4.4. ………………………………………….. patients & child with carries teeth. patients & child with carries teeth.

Antihistamine syrup formulation Antihistamine syrup formulation .. etc .. etc Page 243Page 243

Antimicrobial PreservativesAntimicrobial PreservativesThe The amountamount of required preservative of required preservative for protectionfor protection

depends on:depends on:1.1. AmountAmount of of …………………….……………………. for microbial growth; for microbial growth;2.2. NatureNature & inherent & inherent preservativepreservative activity of activity of somesome

formulativeformulative materials (i.e. many flavoring oils); materials (i.e. many flavoring oils);3.3. ………………………………………….. of the of the preservativepreservative itself. itself. Some preservatives & correspondent usual Some preservatives & correspondent usual

concentration:concentration:1.1. Benzoic acid or Sodium benzoateBenzoic acid or Sodium benzoate 0.1 – 0.2%0.1 – 0.2%2.2. Combinations of m., e., p., b. parbens Combinations of m., e., p., b. parbens total 0.1%total 0.1%3.3. AlcoholAlcohol 15 – 20 %15 – 20 %4.4. Propylene glycol & GlycerinPropylene glycol & Glycerin 1 ml / 1ml.1 ml / 1ml.

Methods for Preservation of SyrupsMethods for Preservation of Syrups

I.I. StorageStorage at at ↓↓ temperature; temperature;

II.II. AdditionAddition of of preservativespreservatives such as glycerin, parabens; such as glycerin, parabens; alcohol,..etc.alcohol,..etc.

III.III. MaintenanceMaintenance of a of a ↑↑ [] of [] of sucrosesucrose as a part of the as a part of the formulation.formulation.

ExampleExample: Rx: Rx

Active drugActive drug 5 mL volume occupied5 mL volume occupied

Other drug solidsOther drug solids 3 ml volume occupied3 ml volume occupied

GlycerinGlycerin 15 mL15 mL

SucroseSucrose 25 g25 g

Ethanol 95 %Ethanol 95 % q.s.q.s.

Purified waterPurified water q.s.q.s. 100 mL100 mL

How much alcohol would be required to preserve this prescription? How much alcohol would be required to preserve this prescription?

Answer:Answer:1.1. S. Syrup (85 %w/v) has s.g = 1.313, thus,S. Syrup (85 %w/v) has s.g = 1.313, thus,2.2. 85 g sucrose are in 100 ml 131.3 g of solution. 131.385 g sucrose are in 100 ml 131.3 g of solution. 131.33.3. 131.3g – 85g = 46.3 g or 46.3 mL of water.131.3g – 85g = 46.3 g or 46.3 mL of water.4.4. 100mL - 46.3 mL = 53.7 mL is the v. of 85 g of sucrose.100mL - 46.3 mL = 53.7 mL is the v. of 85 g of sucrose.5.5. Thus, 85 g of sucrose preserves 46.3 mL of water.Thus, 85 g of sucrose preserves 46.3 mL of water.So,So, 85 g → 46.3 mL85 g → 46.3 mL

25 g → X,25 g → X, thus, X = 13.62 mL of water preserved.thus, X = 13.62 mL of water preserved.V. Of sucrose is:V. Of sucrose is:85g → 53.7 mL85g → 53.7 mL25g → x25g → xThus, X = 15.7 mLThus, X = 15.7 mL6.6. vv. of . of active drugactive drug + + v.v. of of other drugsother drugs occupies 5 + 3 = 8 mL occupies 5 + 3 = 8 mL7.7. 1 mL1 mL of glycerin of glycerin preservespreserves 1 mL of water & 1 mL of water & occupyoccupy 1 mL. 1 mL.So, glycerin preserves: 15 mL + 15 mL = 30 mL total.So, glycerin preserves: 15 mL + 15 mL = 30 mL total.8.8. The volume taken care = 13.62 + 15.7 + 8 +30 = 67.3 mL. The volume taken care = 13.62 + 15.7 + 8 +30 = 67.3 mL.9.9. 100 ml – 67.3 mL of water preserved = 32.68 ml of water which 100 ml – 67.3 mL of water preserved = 32.68 ml of water which

need preservation.need preservation.

10.10. Since it requires about 18% of alcohol to preserve water:Since it requires about 18% of alcohol to preserve water:

So, So, 18 → 100 mL 18 → 100 mL

x → 32.68 mL, → x = 5.88 mL of alcohol 100%.x → 32.68 mL, → x = 5.88 mL of alcohol 100%.

11.11. But the available alcohol 95%:But the available alcohol 95%:

So, So, CC1 1 . V. V11 = C = C22 . V . V22

100100 . 5.9 = 95 . V. 5.9 = 95 . V2 2 → V→ V2 2 = 6.2 ml of alcohol 95% is = 6.2 ml of alcohol 95% is

required.required.

So, add 6.2 ml of alcohol to the syrup and complete volume up to 100 So, add 6.2 ml of alcohol to the syrup and complete volume up to 100 mL with water.mL with water.

Flavorants or Flavoring agentsFlavorants or Flavoring agents

………………………………………….. flavorants. flavorants.

………………………………………….. flavorants as volatile oils (e.g. orange oil, flavorants as volatile oils (e.g. orange oil, vanilla ..etc.).vanilla ..etc.).

Flavorants must posses sufficient water solubility.Flavorants must posses sufficient water solubility.

Alcohol may added to improve solubility of flavors.Alcohol may added to improve solubility of flavors.

ColorantColorant

EnhanceEnhance the the appealappeal of syrup. of syrup.

Selection of colorant in correlation with .Selection of colorant in correlation with .……………….. (i.e. green with mint, brown with ……………….. (i.e. green with mint, brown with chocolate, etc.).chocolate, etc.).

Colorant must be:Colorant must be:

1.1. .………………..;.………………..;

2.2. .……………….. with other syrup components;.……………….. with other syrup components;

3.3. Color Color stablestable at the at the pHpH range & range & underunder the intensity the intensity of of lightlight that the syrup is likely encountered during that the syrup is likely encountered during its shelf-life.its shelf-life.

Preparation of SyrupsPreparation of Syrups

Preparation of syrup Preparation of syrup depends depends on on chemical chemical & & physicalphysical characteristics of the ingredients involved in characteristics of the ingredients involved in formulation.formulation.

There are There are 4 methods4 methods for syrup preparation: for syrup preparation:

1.1. Solution of the ingredients .………………..;Solution of the ingredients .………………..;

2.2. Solution by agitation .………………..;Solution by agitation .………………..;

3.3. AdditionAddition of of sucrosesucrose to a to a medicated liquidmedicated liquid or to a or to a flavored liquid;flavored liquid;

4.4. .………………....………………...

Solution with the Aid of HeatSolution with the Aid of Heat Advantages of this method:Advantages of this method:

1.1. .………………...……………….. method; method;

2.2. The heat provide The heat provide .………………...……………….... Disadvantages of this method:Disadvantages of this method:

1.1. Problems arise when Problems arise when .………………...……………….. ingredients are ingredients are used;used;

2.2. .………………...……………….. of sucrose known as inversion: of sucrose known as inversion:

Sucrose → glucose (dextrose) + fructose (levolose);Sucrose → glucose (dextrose) + fructose (levolose);

3.3. .………………...……………….. of the sucrose (browning of the of the sucrose (browning of the syrup);syrup);

Preparation procedure:Preparation procedure:

1.1. Weigh 85 g of sucrose;Weigh 85 g of sucrose;

2.2. Place them in 100 ml of volumetric flask;Place them in 100 ml of volumetric flask;

3.3. AddAdd hot hot waterwater & & mixmix tell complete tell complete dissolutiondissolution of of sucrose;sucrose;

4.4. AddAdd water water upup to to volumevolume..

5.5. DissolveDissolve or or addadd as as dissolveddissolved other components other components such as flavor, color, medicine, & preservatives;such as flavor, color, medicine, & preservatives;

6.6. Fill in bottles then, close bottles after cooling.Fill in bottles then, close bottles after cooling.

Solution by Agitation Solution by Agitation withoutwithout the the AidAid of of HeatHeat Advantages of this method:Advantages of this method:

1.1. It is used for It is used for .………………...……………….. ingredients; ingredients;

2.2. AvoidAvoid sugar sugar .………………...……………….. & & ..………………..………………....

Disadvantages of this method:Disadvantages of this method:

1.1. .………………...……………….. & & .………………...……………….. are are employed for large scale preparation;employed for large scale preparation;

2.2. Needs Needs .………………...……………….. of preparation; of preparation;

3.3. .………………...……………….. to preservation. to preservation.

Preparation Procedure:Preparation Procedure:

1.1. Put Put sugarsugar & other & other formulativeformulative agentsagents in large vessel in large vessel to permit thorough agitation; to permit thorough agitation;

2.2. Mix well tell Mix well tell completecomplete dissolutiondissolution of sugar & other of sugar & other solublesoluble ingredients; ingredients;

3.3. DrugsDrugs are .……………….. .……………….. & are .……………….. .……………….. & then, added to syrup;then, added to syrup;

4.4. Add water Add water upup to to volumevolume;;

5.5. .……………….. .……………….. directlydirectly to syrup because it needs to syrup because it needs long time to be dissolvedlong time to be dissolved..

Addition of sucrose to Medicated liquid or to a Flavored LiquidAddition of sucrose to Medicated liquid or to a Flavored LiquidIt is frequently It is frequently usedused when .……………….. or .……………….. are when .……………….. or .……………….. are

employed as the employed as the sourcesource of medications. of medications.

These fluid extracts are .………or ……….. preparations.These fluid extracts are .………or ……….. preparations.

If the If the alcoholalcohol solublesoluble componentscomponents are .……………….., means of are .……………….., means of ↑ ↑ their their .……………….. are employed..……………….. are employed.

If the .………………..If the .……………….. components components are .……………….. components, are .……………….. components, they are generally removed by:they are generally removed by:

1.1. MixingMixing the tincture or fluid extract with .………………..; the tincture or fluid extract with .………………..;2.2. LeaveLeave the mixture to stand tell .……………….. of water insoluble the mixture to stand tell .……………….. of water insoluble

compounds;compounds;3.3. .………………....………………...4.4. Add sucrose to the filtrate & complete the procedure.Add sucrose to the filtrate & complete the procedure.If fluid extracts (drug/s) are If fluid extracts (drug/s) are .………………...……………….. add them directly to add them directly to a a ..

………………..……………….. to medicate it. to medicate it.

PercolationPercolation

Types of percolation:Types of percolation:I.I. Percolation of .……………….. to prepare syrup or;Percolation of .……………….. to prepare syrup or;II.II. Percolation of .……………….. components:Percolation of .……………….. components:1.1. Preparation of extract;Preparation of extract;2.2. AddAdd syrupsyrup to the .……………….. to achieve the desired to the .……………….. to achieve the desired

syrup.syrup.Preparation of Ipecac Syrup: Preparation of Ipecac Syrup: 1.1. Prepare the Prepare the extractextract by .………………..; by .………………..;2.2. Add .……………….. & .……………….. to the Add .……………….. & .……………….. to the

percolated ipecacpercolated ipecac..The drug The drug ipecacipecac consists of the consists of the dried rhizomedried rhizome & roots of & roots of

Cephaelis ipecacuanha.Cephaelis ipecacuanha.The The extractedextracted alkaloidsalkaloids by .……………….. with . by .……………….. with .

………………..……………….. solvent are: emetine, cephaeline, & solvent are: emetine, cephaeline, & psychotrine.psychotrine.

It is an emetic syrup.It is an emetic syrup.Usual dose is Usual dose is 1515 ml for .……………….. in children ml for .……………….. in children

when stomach evacuation is desired.when stomach evacuation is desired.VomitingVomiting is achieved within is achieved within ½½ hour in 80% of treated hour in 80% of treated

children.children.AbuseAbuse of this syrup was in of this syrup was in young womenyoung women in attempt to in attempt to

.………………....………………...ExcessExcess of of emetineemetine in tissue due to excess use cause in tissue due to excess use cause

cardiaccardiac muscle muscle damagedamage..Toxic symptoms are:Toxic symptoms are:1.1. .………………...………………..;;2.2. .………………...……………….. symptoms; symptoms;

3.3. .………………...………………....

ElixirsElixirs

Elixirs are, sweetened, flavored, hydro-alcoholic Elixirs are, sweetened, flavored, hydro-alcoholic solutions intended for oral use.solutions intended for oral use.

Types of elixirs:Types of elixirs:1.1. Non-medicated elixir → employed as vehicle.Non-medicated elixir → employed as vehicle.2.2. Medicated elixir → employed for therapeutic effect Medicated elixir → employed for therapeutic effect

of the drug they contain.of the drug they contain.

SyrupSyrup ElixirElixir .……………….. .……………….. Less sweetLess sweet

.……………….. .……………….. Less viscoseLess viscose .……………….. .……………….. Lower sucrose contentLower sucrose content

Lower dissolving capacityLower dissolving capacity Higher dissolving Higher dissolving capacitycapacity .……………….. .……………….. Simple manufacturingSimple manufacturing .……………….. .……………….. More stableMore stable

The The amountamount of of alcoholalcohol in elixir depends on in elixir depends on solubilitysolubility of of dissolved agents.dissolved agents.

Elixir with 10 – 12 % alcohol don’t need preservatives.Elixir with 10 – 12 % alcohol don’t need preservatives.This alcoholic content represents This alcoholic content represents DisadvantageDisadvantage for: for:1.1. .………………...……………….. patients; patients;2.2. AdultsAdults who who .………………...……………….. consumption; consumption;3.3. Also represents another disadvantage for many Also represents another disadvantage for many ..

………………..………………....Because of their Because of their .………………...……………….. & & .………………...……………….. oils oils

content, elixirs must be content, elixirs must be storedstored in: in:1.1. Tightly Tightly .………………...……………….. containers; containers;2.2. .………………...……………….. containers; containers;3.3. In In .………………...……………….. place. place.

Preparation of ElixirsPreparation of Elixirs

1.1. By simple solution (By simple solution (.………………...………………..); );

2.2. By mixture of 2 liquid ingredients:By mixture of 2 liquid ingredients:Dissolve alcohol soluble ingredients;Dissolve alcohol soluble ingredients;

Dissolve water soluble ingredients separately;Dissolve water soluble ingredients separately;

Add .……………….. solution to the .……………….. one Add .……………….. solution to the .……………….. one ( don’t make the reverse).( don’t make the reverse).

Add the desired .……………….. up to volume.Add the desired .……………….. up to volume.

Frequently the final mixture is not clear. What is the reason Frequently the final mixture is not clear. What is the reason behind this?behind this?

What can you do, if the obtained solution is cloudy?What can you do, if the obtained solution is cloudy?

What is the role of Glycerin; Syrup; What is the role of Glycerin; Syrup; Sorbitol & Propylene glycol in in Sorbitol & Propylene glycol in in Elixir Formulation?Elixir Formulation?

1.1. Contribution Contribution .………………...……………….. of the of the Hydro-alcoholic solvent;Hydro-alcoholic solvent;

2.2. Assist the Assist the .………………...……………….. of the of the solute;solute;

3.3. .………………...……………….. of the preparation of the preparation

4.4. .………………...……………….. of the formulation. of the formulation.

Non-Medicated elixirs in extemporaneous Non-Medicated elixirs in extemporaneous preparations:preparations:

1.1. Addition of a drug Addition of a drug .………………...……………….. vehicle; vehicle;

2.2. Dilution of an Dilution of an .………………...………………..( amount of alcohol ( amount of alcohol must be equal in the two elixirs)must be equal in the two elixirs)..

The selection of a vehicle depends on:The selection of a vehicle depends on:.………………...……………….. & & .………………...……………….. of the drug in both of the drug in both ..

………………..……………….. & & .………………...………………....

The amount of alcohol must be only slightly The amount of alcohol must be only slightly above the amount which is required to: above the amount which is required to:

1.1. .………………...………………..2.2. .………………...……………….. of the drug. of the drug.3.3. Flavors, Colors and all components must be Flavors, Colors and all components must be

compatible.compatible.

Medicated ElixirsMedicated Elixirs

Usually most elixirs contains only Usually most elixirs contains only ..

………………..……………….. single therapeutic agent. single therapeutic agent.

Physician prefer this kind of elixir.Physician prefer this kind of elixir.

What is the advantage of having a What is the advantage of having a single drug in the elixir?single drug in the elixir?

Phenobarbital elixirsPhenobarbital elixirs

Page 247Page 247 Digoxin elixir & figures. Page 251Digoxin elixir & figures. Page 251